Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 主要终点
- The width of the alveolar bone
研究概览
简要总结
An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.
详细描述
The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years
- •a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
- •a tooth requiring extraction
排除标准
- •thyroid dysfunctions
- •diabetes mellitus
- •history of a chronic use of corticosteroids (>6 months)
- •history of oral/intravenous bisphosphonates within the past 2 years
- •history of other systemic conditions that could affect bone integrity.
结局指标
主要结局
The width of the alveolar bone
时间窗: up to 6 months
Dimensional changes in the width of the alveolar bone following tooth extraction
次要结局
未报告次要终点
研究者
Se-Lim Oh
Clinical Associate Professor
University of Maryland, Baltimore